Low-Intensity Focused Ultrasound and the Complex Patient
NCT ID: NCT06297200
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2024-12-04
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Pain, Craving, and Anxiety measures
Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.
Low-Intensity Focused Ultrasound
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
Low-Intensity Focused Ultrasound - sham
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Interventions
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Low-Intensity Focused Ultrasound
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
Low-Intensity Focused Ultrasound - sham
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Eligibility Criteria
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Inclusion Criteria
2. Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
3. Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
4. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.
5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
6. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.
Exclusion Criteria
2. Previous spine surgery
3. Current substance use disorder other than OUD or tobacco use disorder
4. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
5. Chronic Pain Conditions other than chronic back pain
6. Daily opiate use other than buprenorphine/methadone for OUD/pain control
7. Pregnant or breastfeeding
8. History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
9. History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
10. Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
11. Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
12. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
18 Years
65 Years
ALL
No
Sponsors
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Salem VA Medical Center
UNKNOWN
Washington DC VA Medical Center
UNKNOWN
Virginia Polytechnic Institute and State University
OTHER
Responsible Party
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Wynn Legon
Assistant Professor
Locations
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Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-050
Identifier Type: -
Identifier Source: org_study_id
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